RUGBY ACETAMINOPHEN- acetaminophen liquid

Rugby by

Drug Labeling and Warnings

Rugby by is a Otc medication manufactured, distributed, or labeled by Rugby Laboratories, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each 5mL)

Acetaminophen 160 mg

Purpose

Pain reliever-Fever reducer

Uses

temporarily reduces fever and relieves minor aches and pains caused by

• common cold
• flu
• headache
• sore throat
• toothache

Warnings

Liver warning

This product contains acetaminophen. Severe liver damage may occur if your child takes

• more than 5 doses in 24 hours, which is the maximum daily amount
• with other drugs containing acetaminophen.

Allergy alert: acetaminophen may cause severe skin reactions.

Symptoms may include:

• skin reddening
• blisters
• rash

If a skin reaction occurs, stop use and seek medical help right away.

Sore throat warning

If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Do not use

• with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
• if your child is allergic to acetaminophen or any of the inactive ingredients in this product

Ask a doctor before use if your child has liver disease

Ask a doctor or pharmacist before use if your child is taking the blood thinning drug warfarin

When using this product, do not exceed recommended dose (see overdose warning)

Stop use and ask a doctor if

• pain gets worse or lasts more than 5 days
• fever gets worse or lasts more than 3 days
• new symptoms appear
• redness or swelling is present. These could be signs of a serious condition.

Keep out of reach of children.

Overdose warning

Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical even if you do not notice any signs or symptoms.

Directions

• this product does not contain directions or complete warnings for adult use
• find right dose on chart. If possible, use weight to dose; otherwise, use age
• give dose every 4 hours while symptoms last
• do not give more than 5 doses in 24 hours
• use enclosed dosing cup only. Do not use with any other device.
• mL = milliliter

Weight	Age	Dose
72 - 95 lbs	11 years	15mL
60 - 71 lbs	9 - 10 years	12.5mL
48 - 59 lbs	6 - 8 years	10mL
36 - 47 lbs	4 - 5 years	7.5mL
24 - 35 lbs	2 - 3 years	5mL
under 24 lbs	under 2 years	ask a doctor

Other information

• each 5 mL contains: sodium 1 mg
• store at 20 - 25°C (68 - 77°F)

Inactive ingredients

artificial flavor, citric acid anhydrous, D&C Red #33, FD&C Red #40, glycerin, polyethylene glycol 1450, propylene glycol, purified water, saccharin sodium, sodium benzoate, sorbitol.

Questions or comments?

1-800-645-2158

SPL UNCLASSIFIED SECTION

Distributed by: Rugby Laboratories
17177 N Laurel Park Drive, Suite 233
Livonia, MI 48152

PRINCIPAL DISPLAY PANEL - 118 mL Bottle Label

Rugby®

NDC: 0536-0122-97

RELIEVES CHILDREN'S
Pain
&Fever
ACETAMINOPHEN
ORAL SOLUTION

CHERRY FLAVORED

SUGAR FREE
Aspirin & Alcohol Free

4 fl oz (118 mL) 160mg per 5mL

INGREDIENTS AND APPEARANCE

RUGBY  ACETAMINOPHEN
acetaminophen liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0536-0122
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	160 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
BENZOIC ACID (UNII: 8SKN0B0MIM)
SORBITOL (UNII: 506T60A25R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
FD&C RED NO. 40 (UNII: WZB9127XOA)
WATER (UNII: 059QF0KO0R)
SUCROSE (UNII: C151H8M554)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
CHERRY (UNII: BUC5I9595W)
POLYETHYLENE GLYCOL 1450 (UNII: OJ4Z5Z32L4)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)

Product Characteristics
Color	red	Score
Shape		Size
Flavor	CHERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0536-0122-97	118 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/28/2011	01/31/2021
2	NDC: 0536-0122-85	473 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/28/2011	01/31/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part343	04/28/2011	01/31/2021

Labeler - Rugby Laboratories, Inc. (079246066)